FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program

Approval demonstrates the potential of Zilosul™ to address an unmet medical need in OA which effects more than 72 million people in the US, EU5, and Canada

KEY HIGHLIGHTS

• FDA Fast Track Designation for Pentosan Polysulfate Sodium (Zilosul™/PPS) offers pathways to expedite development of Paradigm's osteoarthritis clinical program.
• FDA Fast Track acknowledges osteoarthritis as a serious disease with unmet needs and the potential for PPS to offer a treatment for OA.
• Fast Track designation allows Paradigm the opportunity to interact and collaborate with the FDA more frequently during program development. This enables a stronger overall program in line with the FDA's expectations and provides opportunity for shorter review timelines.

Actions to Expedite Development and NDA Review

• Opportunity to interact and collaborate with FDA more frequently during program development, for example, to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers.
• Other meetings may be scheduled as appropriate (e.g., to discuss potential for accelerated approval request, the structure and content of a New Drug Application (NDA), and other critical issues).
• In addition, such a product could be eligible for priority review request at the time of NDA submission. Priority review reduces the review time from 10 months to 6 months.

MELBOURNE, Australia, April 13, 2022 /PRNewswire/ -- Paradigm Biopharmaceuticals (ASX: PAR) a clinical stage biopharmaceutical company focused on repurposing existing molecules for new indications with unmet clinical needs, is excited to announce that the FDA has granted Fast Track Designation for the company's phase III program investigating Pentosan Polysulfate Sodium (PPS) for the treatment of osteoarthritis (OA).

The FDA Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of providing important new therapies to patients more quickly. This Fast Track Designation from the FDA acknowledges that OA can be a serious disease and that preliminary data demonstrates that Zilosul™ has the potential to address unmet medical challenges associated with the disease.

Dr. Donna Skerrett, Paradigm Chief Medical Officer and Interim CEO commented: "This is welcome news from the FDA as the company continues to gain momentum in site activation and participant screening across the 56 selected sites in the U.S. Given the need to improve therapeutic options for patients suffering from pain and loss of functionality associated with OA, we are excited to have this Fast Track Designation granted for Zilosul™ and the regulatory support it provides in expediting the phase III development program to advance this promising treatment to patients sooner."

Dr. Skerrett continued, "Paradigm believes Zilosul™ would represent an important medical advance in the treatment of debilitating osteoarthritis pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications."

OA is a chronic degenerative disease characterized by a progressive loss of cartilage, leading to pain, loss of joint function and disability. It is the most prevalent form of joint disease, affecting up to 16% of the population in the developed world, with more than 72 million people in the US, EU5, Canada and Australia suffering from OA.ⁱ

The prevalence of OA is increasing in line with the aging population and increasing rates of obesity. By 2030, the number of people suffering from OA in the US alone is predicted to increase by 86% to 67 million.ⁱⁱ If we assume a similar increase across the other markets listed above, even allowing for lower rates of obesity in non-US markets, it is estimated that more than 120 million people will be suffering from OA by 2030.

For more information about Paradigm's acceptance into the FDA's Fast Track Program please visit: https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02509764-3A591647?access_token=83ff96335c2d45a094df02a206a39ff4

Additional information on all of Paradigm's programs and clinical trials can be found at: www.ClinicalTrials.gov  (002 - NCT04809376, 006 - NCT04814719)

For more information about Paradigm Biopharmaceuticals please visit:  https://paradigmbiopharma.com/  

About Paradigm Biopharmaceuticals: Paradigm Biopharmaceuticals (ASX: PAR) is a global biopharmaceutical company driven to improve patients' lives through repurposing existing drugs and pioneering new solutions for unmet medical needs.  The company aims to identify and leverage new applications for drugs in late-stage development. 

Since their founding in 2014, Paradigm has successfully identified, repurposed, and patented Pentosan Polysulfate Sodium (PPS), for the management of pain and inflammation, associated with musculoskeletal disorders including osteoarthritis (under the trademark Zilosul®) and the rare disease mucopolysaccharidosis. Paradigm's approach to market is driven by core competencies with experienced management at both board and executive levels and in clinical and commercial

ⁱ Global Health Data Exchange, Institute for Health and Metrics Evaluation, University of Washington. Accessed June 2021 http://ghdx.healthdata.org/gbd-results-tool

ⁱⁱ OARSI. Osteoarthritis: A Serious Disease, Submitted to the U.S. Food and Drug Administration December 1, 2016

SOURCE Paradigm Biopharmaceuticals